510(k) K182874
K182874 is an FDA 510(k) premarket notification submitted by Spirosure, Inc. for the device "Fenom Pro Nitric Oxide Test". The FDA issued a decision of Substantially Equivalent on February 13, 2019. The device falls under product code MXA (System, Test, Breath Nitric Oxide), a Class II device regulated under 21 CFR 862.3080.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2019
- Date Received
- October 12, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Breath Nitric Oxide
- Device Class
- Class II
- Regulation Number
- 862.3080
- Review Panel
- CH
- Submission Type